Methods for repairing bone using a high pressure cement injection

ABSTRACT

A method for treating osteoporosis or for repairing a join between bone and a prosthetic pin by injecting cement dispensed under high pressure from a cement gun into the bone cavity at one end of the medullary canal or into an interstice in the join formed between the prosthetic pin and cement in the cavity, anchoring the pin in the cavity, employs an adaptor at entry and exit ends. The adaptor has a shank portion with a self tapping external thread tapering from a connecting portion having an internal thread for attachment to a zerk, and radially outward wings, forming fingerpieces by which the shank portion can be rotated. An internal glue passageway extends completely through the adapter. A kit for injecting cement includes two adapters, a zerk, a high pressure lever action hydraulic gun for cement, two flexible connecting hoses, two plugs and a pressure release valve.

FIELD OF THE INVENTION

The invention relates to a method for applying cement under pressure to bone cavities or interstices, for example for treating osteoporosis and for repairing bone prosthesis in situ, particularly artificial hip joints,

BACKGROUND OF THE INVENTION

A conventional technique for treating hip diseased hip joints involves the replacement of the patients diseased hip joint by the substitution of a prosthetic hip joint having a pin which is anchored by cement in the femur cavity to secure the hip joint to the femur. When fitting the joint, the top of the femur in the region of the trabeculae is cut open and the bone marrow removed through the top opening by a scooping and suction technique, emptying the bone cavity or intra/medullary canal for the receipt of the pin and a two-part epoxy cement injected into the cavity through the top opening to spread around the pin using a gun, similar in construction to a caulking gun. Caps of various selected sizes are required to be fitted around the gun nozzle to seal the top opening during injection in an attempt to permit a relatively modest pressure increase to perhaps 2-3 p.s.i. in an attempt to completely fill all interstices around the pin.

However, the pin is made of titanium which is much harder than the cement and as a result of the difference in hardness, after the joint has been in use for a number of years, typically about 10 years, hairline cracks or interstices develop at the interface of the titanium pin and epoxy cement. The conventional remedy has required that the entire joint (pin) be removed and replaced which is effectively a repeat of the earlier procedure which is an undesirable major operation.

It is also known to completely fill a medullary canal with cement through an opening cut in the bone in the upper end for the treatment of osteoporosis.

Examples of devices and mechanisms previously used to instal the artificial joint are described in the catalogue of Stryker Instruments, Ml, PT No 1000-119 rev C; PT. NO. 1000-310 REV B1; BP NO 1000-340 for their bone preparation systems, third generation cementing technique and cement injection system.

SUMMARY OF THE INVENTION

It is one object of the invention to provide a method which will obviate the requirement to remove and replace the artificial joint as a result of the development of hairline cracks or interstices at the interface of the prosthesis pin and cement.

It is another object of the invention to provide a method permitting the injection of the cement at very high pressures into the bone cavity or medullary canal and interstices to ensure maximum intrusion of cement therein.

According to one aspect, the invention provides a method for repairing a join between a prosthetic anchoring pin and a bone receiving the pin, without removing the pin from the bone including the steps of:

tapping entry and exit bores at spaced apart locations in the bone in communication with opposite ends of an interstice formed at a interface of the pin;

providing a pair of adaptors and a zerk, each adaptor comprising an elongate body with leading, penetrating and rear, connecting ends, the body having a pointed penetrating shank which tapers outward as it extends rearward from the leading end and is formed with an external self-tapping screw thread and a fingerpiece comprising a pair of wings protruding radially outward adjacent the rear end and an internal cement passageway extending axially completely through the body communicating with leading and rear ends, the rear end of at least one adaptor being provided with an internal screw thread meshing with a complementary thread on the zerk and manually screwing the adaptors into sealing engagement with respective bores;

providing a high pressure cement gun and attaching the zerk to the cement outlet of the cement gun and to the rear end of said at least one adaptor;

providing an outlet hose for the cement gun and securing the outlet hose to the zerk

and injecting cement under high pressure from the gun through said at least one adaptor to penetrate throughout the interstice traveling from the entry hole to the exit hole thereby filling the interstice to seal and repairing the join.

The invention enables repair of a hairline crack or interstice in a join between a prosthetic anchoring pin and a anchoring cement in bone receiving the pin, without removing the pin from the bone.

According to another aspect, the invention provides A method for treating osteoporosis comprising the steps of:

tapping entry and exit bores at spaced apart locations in an affected bone in communication with opposite ends of a medullary canal of the bone:

providing a pair of adaptors and a zerk, each adaptor comprising an elongate body with leading, penetrating and rear, connecting ends, the body having a pointed penetrating shank which tapers outward as it extends rearward from the leading end and is formed with an external self-tapping screw thread and a fingerpiece comprising a pair of wings protruding radially outward adjacent the rear end and an internal cement passageway extending axially completely through the body communicating with leading and rear ends, the rear end of at least one adaptor being provided with an internal screw thread meshing with a complementary thread on the zerk and, manually screwing the adaptors into sealing engagement with respective bores;

providing a high pressure cement gun and attaching the zerk to the cement outlet of the cement gun and to the rear end of said at least one adaptor;

providing an outlet hose for the cement gun and securing the outlet hose to the zerk,

and injecting cement under high pressure from the gun through said at least one adaptor into said medullary canal to penetrate throughout the canal traveling from the entry hole to the exit hole thereby filling the canal and reinforcing the bone.

The screw threaded adaptor and zerk seal against back pressure enabling a lever operated, hydraulic action, gun known for greasing automobiles and which is widely available at low cost to be used for regluing operations to apply glue rapidly under very high pressure (e.g. 7,500 psi-10,500 p.s.i.). Furthermore, as the adapters have fingerpieces they may, with zerks attached, readily be screwed by hand into pilot bores tapped in the boney mass

Aspects of various devices described herein are described in my application Ser. No: 09/346861, filed: Jul. 2, 1999, the disclosure of which is incorporated herein by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

Specific embodiments of the invention will now be described by way of example only and with reference to the accompanying drawings in which:

FIG. 1 is a schematic elevational view showing the injection of cement into a person's femur for the treatment of osteoporosis;

FIG. 2 is an enlarged diagrammatic view of the femur only undergoing cement injection into the medullary canal;

FIG. 3 is a schematic elevation showing the injection of cement into a person's femur for the repair of a prosthesis pin anchoring;

FIG. 4 is an enlarged view of the femur undergoing cement injection for during prosthesis repair;

FIG. 5 is an elevational view, of a high pressure gun of known type connected by a flexible hose to a zerk screw-fitted in a rear end of the adaptor; and,

FIG. 6 is an elevational view, partly in cross-section, of the adaptor and zerk exploded apart for clarity.

DESCRIPTION OF PARTICULAR EMBODIMENTS

As shown in FIG. 6, and as described in my prior application identified above, the adaptor 1 comprises an elongate, steel body 2 with leading, penetrating and rear, connecting ends, 3 and 4, respectively, and a pointed penetrating shank 5 which tapers outward as it extends rearward from the leading end 3 and is formed with an external, self-tapping screw thread 6. A fingerpiece 7 comprises a pair of wings 8 protruding radially outward and forward from a radially enlarged hub portion 9 having an internal screw thread for attachment to a zerk 13. An axial glue passageway 12 is bored completely through the body so as to communicate with leading and rear ends.

The zerk 13 is of the well known type widely used as a grease nipples and comprises a steel body 14 having a central bore 15 with spring loaded non return ball valve 16 at an inlet end and an externally threaded connecting portion 17 at an outlet end for connection to the adaptor.

The zerk 13 enables connection, via a known pressure adaptor hose 18 and coupler 19, to a high pressure, manually operated, hydraulic action gun 20 widely used for greasing automobiles.

As shown in FIGS. 1 and 2, in a method for treating osteoporosis entry a first adapter 1 with a zerk attached to a rear end and another adaptor 1 with a manual pressure release valve 21 of well known type attached to a rear end are manually screwed into entry and exit bores tapped adjacent lower and upper ends of an affected femur 22 in communication with opposite upper ends of the medullary canal or central bone cavity 24. A pressure hose 18 connects the outlet of the gun 20 to the zerk and another hose 25 connects the outlet of the valve 21 to a collection jar. Suitable premixed epoxy cement is then injected into the medullary canal under high pressure selectively controlled by the valve 21 to advance up the canal displacing the marrow therefrom. The procedure can be monitored by MRI or X-ray to detect the progress of the cement up the canal. Appearance of the cement in the hose will also indicated that the canal is completely full.

The presence of the screw thread on the adaptors, and the provision of the zerk enable injection of cement at very high pressure while the epoxy has flexural characteristics compatible to bone providing good reinforcement with minimal body intrusion.

As shown in FIGS. 3 and 4, the procedure for repair of the artificial hip joint 30 by re-cementing a hairline crack 31 or interstice which forms over time around the pin 33 between the surface of the relatively hard titanium pin and the softer epoxy cement is similar, in that entry and exit bores communicating with the interstice are tapped in the boney mass at the lower tip of the pin and adjacent the upper end of the femur. Epoxy cement is then injected therein under the high pressures typical of conventional grease guns, for example, 5,500, 7,500 or 10,500 P.S.I, monitoring the procedure as above, to substantially completely fill, reseal and repair the join.

Clearly this involves only a minimally invasive procedure obviating the trauma associated with removal and replacement of the prosthesis. It is clearly very much faster and very much less expensive, both in terms of applied cost and materials. 

I claim:
 1. A method for repairing a join between a prosthetic anchoring pin and a bone receiving the pin, without removing the pin from the bone including the steps of: tapping entry and exit bores at spaced apart locations in the bone in communication with opposite ends of an interstice formed at a interface of the pin; providing a pair of adaptors and a zerk, each adaptor comprising an elongate body with leading, penetrating and rear, connecting ends, the body having a pointed penetrating shank which tapers outward as it extends rearward from the leading end and is formed with an external self-tapping screw thread and a fingerpiece comprising a pair of wings protruding radially outward adjacent the rear end and an internal cement passageway extending axially completely through the body communicating with leading and rear ends, the rear end of at least one adaptor being provided with an internal screw thread meshing with a complementary thread on the zerk and manually screwing the adaptors into sealing engagement with respective bores; providing a high pressure cement gun and attaching the zerk to the cement outlet of the cement gun and to the rear end of said at least one adaptor; providing an outlet hose for the cement gun and securing the outlet hose to the zerk and injecting cement under high pressure from the gun through said at least one adaptor to penetrate throughout the interstice traveling from the entry hole to the exit hole thereby filling the interstice to seal and repairing the join.
 2. The method of claim 1 wherein the bone is a femur, the pin is part of a prosthetic hip joint and the entry end is located below the exit end and adjacent a lower tip of the pin and the exit end is located adjacent an upper end of the femur.
 3. The method of claim 2 including the step of providing a pressure release valve on the a rear end of the adapter at the exit hole and thereby selectively controlling the interstitial pressure during injection step.
 4. The method of claim 1 including the step of providing a pressure release valve on the a rear end of the adapter at the exit hole and thereby selectively controlling the interstitial pressure during injection step.
 5. The method of claim 1 including the step of monitoring receipt of cement into the interstice by employing one of a magnetic resonance imaging and X-ray technique.
 6. A method for treating osteoporosis comprising the steps of: tapping entry and exit bores at spaced apart locations in an affected bone in communication with opposite ends of a medullary canal of the bone; providing a pair of adaptors and a zerk, each adaptor comprising an elongate body with leading, penetrating and rear, connecting ends, the body having a pointed penetrating shank which tapers outward as it extends rearward from the leading end and is formed with an external self-tapping screw thread and a fingerpiece comprising a pair of wings protruding radially outward adjacent the rear end and an internal cement passageway extending axially completely through the body communicating with leading and rear ends, the rear end of at least one adaptor being provided with an internal screw thread meshing with a complementary thread on the zerk and, manually screwing the adaptors into sealing engagement with respective bores; providing a high pressure cement gun and attaching the zerk to the cement outlet of the cement gun and to the rear end of said at least one adaptor; providing an outlet hose for the cement gun and securing the outlet hose to the zerk; and injecting cement under high pressure from the gun through said at least one adaptor into said medullary canal to penetrate throughout the canal traveling from the entry hole to the exit hole thereby filling the canal and reinforcing the bone.
 7. The method of claim 6 including the step of providing a pressure release valve on the rear end of the adapter at the exit hole and thereby selectively controlling the canal pressure thereby during injection.
 8. The method of claim 7 wherein the bone is a femur and the entry and exit ends communicate with lower and upper ends, respectively, of the of the medullary canal and bone marrow is progressively displaced through the exit end by the cement entering the entry end.
 9. The method of claim 6 including the step of providing a pressure release valve on the a rear end of the adapter at the exit hole and thereby selectively controlling the interstitial pressure during injection.
 10. The method of claim 9 including the step of monitoring receipt of cement into the interstice by employing one of a magnetic resonance imaging and X-ray technique. 